Parents' Knowledge and Perception of Benefits and Risks Regarding Neonatal Circumcision

NCT01909609 | Completed

• 1 other identifier: HUM00073478
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

Brief Summary

The American Academy of Pediatrics changed their stance on circumcision to "health benefits of newborn male circumcision outweigh the risks and that the procedure's benefits justify access to this procedure for families who choose it" (AAP, 2012). We wonder if parents are aware of guidelines such as those of the AAP. Are parents able to make this medical decision by weighing the risks against the benefits of circumcision, or do they simply use sociocultural/religious reasons to make this decision? We hypothesize that parents are unaware of the specific benefits and risks of circumcision, and make this decision based primarily on sociocultural, religious, and/or familial norms. Expectant parents' knowledge will be assessed via a Qualtrics survey. Participants will be recruited in the OB/GYN clinic sometime between their 24-28 week prenatal visit. We hope to accrue at least 680 participants for this study in order to achieve statistical significance and acquire a range of demographics. Expectant mothers and fathers (and single mothers) will be encouraged to participate. This survey will assess their desire to get their child circumcised when they are born. Participants will be asked to list perceived risks and benefits of circumcision. This will hopefully allow us to see two things: if parents are aware and knowledgeable of the risks and benefits or circumcision, and what they perceive to be risky or beneficial from a medical standpoint. Parents will be randomly given 1 of 2 pieces of information (1 per couple \[or per single mother\]; 1 control, 1 experiment) with different information about circumcision. We will see if there are any outcome differences based on which group the couple randomized into. Follow-up phone call will serve to assess outcome if baby was circumcised and any factors that led up to the decision. This will allow us to see if the AAP stance has any effect on decision making when we compare the control and experiment groups.

Conditions

Circumcision

Keywords

male

Outcome Measures

Primary Outcomes (1)

• Number of children circumcised

  18 weeks

Study Arms (2)

Parent Survival Guide

SHAM COMPARATOR

This arm of the study will focus on the document that is normally given to all parents of newborn infants. It contains information on newborn care such as feeding, cleaning of the baby's penis, etc.

Other: Parent Survival Guide

AAP Documents + Parent Survival Guide.

EXPERIMENTAL

This arm of the study will focus on documents created based off of the American Academy of Pediatrics 2012 policy statement. They contain information on the potential risks and benefits of neonatal circumcision. The Parent Survival Guide contains information on newborn care such as feeding, cleaning of the baby's penis, etc.

Other: AAP Documents; Other: Parent Survival Guide

Interventions

AAP Documents OTHER

AAP Documents + Parent Survival Guide.

Parent Survival Guide OTHER

AAP Documents + Parent Survival Guide.; Parent Survival Guide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be recruited from the Obstetrics clinic. All expectant parents of children are eligible to participate in this study. The study team will include those who do not know the sex of their baby and later exclude those who ultimately have girls from the final survey.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: July 1, 2013
• Primary Completion: June 16, 2017
• Study Completion: June 16, 2017
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

US (1)